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Adult Acute Lymphoblastic Leukemia in RemissionNCT00536601

High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

A study testing etoposide, cyclophosphamide and carmustine in people with Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Read more about this study

Who is it for?
Ages 4 years and older
What is being tested?
etoposide, cyclophosphamide and carmustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteUnited States
Study dates
29 Jun 2006to 9 Jul 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy
  • Recurrent or refractory disease or disease at high risk for recurrence
  • Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen
  • Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score
  • Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits
  • Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits
Show all 42Show fewer
  • Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression
  • Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy
  • Amyloidosis: primary or previously treated
  • Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
  • Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient
  • Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible
  • Life expectancy > 2 months
  • Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation
  • Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or echocardiogram
  • Bilirubin < 3 x normal
  • Alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) < 3 x normal
  • Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics
  • Glomerular filtration rate by renal scan for neuroblastoma patients, to determine dosing parameters
  • Positive cytomegalovirus (CMV) immunoglobulin M (IgM) and/or positive hepatitis serologies demonstrating infection will require an Infectious Disease consult and subsequent clearance
  • Any active infection will require an Infectious Disease consult and subsequent clearance
  • Peripheral Blood Counts of polymorphonuclear neutrophil (PMN) > 1500/uL
  • Platelet (Plt) > 75,000/uL
  • Prior to stem cell storage:
  • No radiation within three weeks before stem cell harvest
  • Bone marrow may be used in conjunction with blood progenitor cells
  • Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but on appropriate anti-retroviral therapy may go autotransplant with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number < 100,000 per microliter and with Infectious Disease clearance
  • Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells; small round blue cell tumor patients must have received either standard therapy or surgical intervention; the disease status and response to therapy must be known prior to transplant to establish the disease status at transplant; amyloidosis patients may proceed to BMT without receiving chemotherapy
  • No serious organ dysfunction unless it is caused by the underlying disease, exclusion criteria include the following:
  • Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, symptomatic angina, life-threatening arrhythmia or hypertension
  • Active bacterial, viral, or fungal infection
  • Active peptic ulcer disease
  • Uncontrolled diabetes mellitus
  • No serious medical or psychiatric illness
  • Not pregnant
  • No psychiatric conditions which would prevent delivery of care; psychology clearance is necessary
  • Allogeneic BMT not possible, or not desirable
  • Age > 65 years
  • No compatible donor identified
  • Estimated risk of graft vs. host disease complications greater than risk of recurrence after autologous BMT
  • Adequate bone marrow or blood stem cell dose obtained:
  • For blood stem cells: total CD 34+ >= 2 x 10^6/kg or if unable to collect this dose, a total nucleated cell bone marrow dose of >= l x 10^8/kg

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors

This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen.

SECONDARY OBJECTIVES:

  1. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen.

II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT).

OUTLINE:

Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.

Being tested
etoposide, cyclophosphamide, carmustine, melphalan, busulfan
Medical subject headings
Congenital Abnormalities, Lymphoma, Extranodal NK-T-Cell, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Neuroectodermal Tumors, Primitive, Peripheral, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • carmustineDrug

    Also called BCNU, BiCNU, bis-chloronitrosourea

    Given IV

  • melphalanDrug

    Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard

    Given IV

  • busulfanDrug

    Also called BSF, BU, Misulfan, Mitosan

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • thiotepaDrug

    Also called Oncotiotepa, STEPA, TESPA, Tespamin

    Given IV

  • total-body irradiationRadiation

    Also called TBI

    Undergo TBI

  • autologous hematopoietic stem cell transplantationProcedure or surgery

    Undergo ASCT

  • autologous-autologous tandem hematopoietic stem cell transplantationProcedure or surgery

    Undergo tandem ASCT

Study groups in NCT00536601
Study groupRoleWhat they receive
Regimen CBV (patients with HL or NHL)ExperimentalPatients receive etoposide intravenously (IV) continuously over 34 hours on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3. Patients undergo ASCT on day 0.
Receives: Drug: etoposide; Drug: cyclophosphamide; Drug: carmustine; Procedure: autologous hematopoietic stem cell transplantation
Regimen M200/M120 (patients with MM or amyloidosis)ExperimentalPatients receive 200 or 120 mg/m^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.
Receives: Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation
Regimen BuC2iv (patients with ALL, AML, HL, or NHL)ExperimentalPatients receive busulfan IV over 2 hours then every 6 hours on days -7 to -4 for 16 total doses and cyclophosphamide IV over 2 hours on days -3 and -2. Patients undergo ASCT on day 0.
Receives: Drug: cyclophosphamide; Drug: busulfan; Procedure: autologous hematopoietic stem cell transplantation
Regimen CT6 (patients with ALL)ExperimentalPatients receive cyclophosphamide IV over 2 hours on days -5 to -4. Patients then undergo TBI twice daily on days -3 to -1. Patients undergo ASCT on day 0.
Receives: Drug: cyclophosphamide; Radiation: total-body irradiation; Procedure: autologous hematopoietic stem cell transplantation
Regimen CTtCp (patients with other solid tumors)ExperimentalPatients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously over 24 hours on days -7 to -4. Patients undergo ASCT on day 0.
Receives: Drug: cyclophosphamide; Drug: carboplatin; Drug: thiotepa; Procedure: autologous hematopoietic stem cell transplantation
Regimen VCp (patients with testicular cancer)ExperimentalPatients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients then undergo a second ASCT on day 0.
Receives: Drug: etoposide; Drug: carboplatin; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Regimen TtC1500/ECpM (patients with NBL or SRBCT)ExperimentalPatients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 2 hours on days -5 to -2. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive carboplatin IV continuously over 24 hours on days -7 to -4, etoposide IV continuously over 24 hours on days -7 to -4, and melphalan IV over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.
Receives: Drug: etoposide; Drug: cyclophosphamide; Drug: melphalan; Drug: carboplatin; Drug: thiotepa; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

    Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.

    Measured: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

Secondary outcomes (3)

  1. Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))

    Toxicities will be reported using descriptive statistics.

    Measured: Up to 100 days after transplantation

  2. Response Rate (Complete Remission)

    Response rates will be reported using descriptive statistics.

    Measured: At 100 days

  3. Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)

    Assessed using the product-limit based Kaplan Meier method.

    Measured: Patients are followed up to maximum of 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2007 (estimated)
  2. Study start29 Jun 2006
  3. Primary completion9 Jul 2018
  4. Study completion9 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00536601
Sponsor's protocol ID
I 72806
Other IDs
NCI-2011-00131, I 72806, P30CA016056
Status last verified
Mar 2021
First submitted
27 Sep 2007
Last updated
22 Apr 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing etoposide, cyclophosphamide and carmustine in people with Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) (time frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00536601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.

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